Job Description
Are you ready to accelerate the development of life-changing therapies? Apex Pharma Solutions is seeking a highly skilled and strategic Senior Clinical Data Manager to join our dynamic team in Boston, MA. In this pivotal role, you will oversee the integrity, quality, and timeliness of clinical data across our global trials, ensuring compliance with regulatory standards and contributing to our mission of improving patient outcomes.
Why Join Us?
We offer a competitive benefits package including comprehensive health coverage, a 401(k) match, and a culture that prioritizes innovation and professional growth. If you have a passion for data integrity and want to work at the forefront of pharmaceutical innovation, we want to hear from you.
Responsibilities
- Lead Data Management Operations: Direct the planning, execution, and monitoring of clinical data management activities for Phase I-IV clinical trials, ensuring alignment with project timelines.
- EDC Management: Manage the implementation and maintenance of Electronic Data Capture (EDC) systems (e.g., Medidata Rave, Veeva Vault) and ensure data entry workflows are optimized.
- Data Integrity & Quality: Enforce rigorous data quality standards and GCP (Good Clinical Practice) compliance. Conduct thorough data cleaning, validation, and reconciliation to ensure data accuracy.
- Regulatory Documentation: Compile and maintain accurate data management deliverables, including Data Management Plans (DMPs), CRF designs, and source data verification (SDV) reports for regulatory submissions.
- Stakeholder Collaboration: Act as the primary liaison between cross-functional teams, including Clinical Operations, Biostatistics, Medical Writing, and Regulatory Affairs, to resolve data discrepancies efficiently.
- Training & Mentorship: Mentor junior data management staff, providing guidance on best practices, system functionality, and regulatory requirements.
Qualifications
- Education: Bachelor’s degree in Life Sciences, Biostatistics, Pharmacy, or a related field; Master’s degree is preferred.
- Experience: Minimum of 5+ years of experience in clinical data management, with a proven track record of leading projects or teams.
- Technical Skills: Proficiency in programming languages such as SAS or R, and experience with SQL for data manipulation is highly desirable.
- System Expertise: Strong knowledge of EDC systems (Medidata Rave, Oracle Clinical, Veeva) and CDISC standards (SDTM, CDASH, DEFINE).
- Certifications: Certified Clinical Data Manager (CCDM) or GCP certification is strongly preferred.
- Communication: Excellent verbal and written communication skills with the ability to present complex data issues to non-technical stakeholders.